NDC 58443-0643 - Australian Gold SPF 15

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58443-0643
Package NDCs from labels
58443-0643-4
Manufacturer
Prime Enterprises, Inc.
Effective date
2023-10-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Australian Gold Instant Bronzer Spray Gel Sunscreen SPF 15Prime Enterprises, Inc.2023-10-31HUMAN OTC DRUG LABEL

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 227 of 266 · 5,317 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
F19 STRNG-MNDANACARDIUM ORIENTALE, ARNICA MONTANA, AURUM METALLICUM, CASTANEA SATIVA, CITRUS SINENSIS, CRATAEGUS MONOGYNA, CYTISUS SCOPARIUS, DANDELION, FAGUS SYLVATICA, FUCHSIA, GORSE, HYDRASTIS CANADENSIS, IGNATIA AMARA, IRON, KALI PHOSPHORICUM, MALUS SYLVESTRIS, NATRUM MURIATICUM, PAEONIA CALIFORNICA, POMEGRANATE, PRUNELLA VULGARIS, ROSA CALIFORNICA, SINAPIS ARVENSIS, YARROW, YERBA SANTAApex Energetics Inc.bec4e5d7-d968-175b-e053-2a95a90a4e0a2024-01-08WarningsExact identifier
unii: 451W47IQ8X
F22 SOMATICAAGRIMONY, CALOCHORTUS TOLMIEI, CIMICIFUGA RACEMOSA, CLEMATIS VITALBA, DANDELION, DIPLACUS AURANTIACUS, ECHINACEA ANGUSTIFOLIA, EHRENDORFERIA CHRYSANTHA, FUCHSIA, HYDRASTIS CANADENSIS, KALI PHOSPHORICUM, LARIX DECIDUA, LATHYRUS ODORATUS, LONICERA CAPRIFOLIUM, NATRUM MURIATICUM, ROSA CALIFORNICA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR, YARROW, YERBA SANTAApex Energetics Inc.bed99bed-3902-5278-e053-2a95a90aeab62024-01-08WarningsExact identifier
unii: 451W47IQ8X
F27 MVONAGRIMONY, ARNICA MONTANA, ARSENICUM ALBUM, ARTEMISIA TRIDENTATA, ASPEN, CHAMOMILE, CHICORY, DICENTRA FORMOSA, EHRENDORFERIA CHRYSANTHA, EUCALYPTUS GLOBULUS, HARDY FUCHSIA, HORSE CHESTNUT, IGNATIA AMARA, JUGLANS REGIA, LACHESIS MUTUS, LARIX DECIDUA, MIMULUS GUTTATUS, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, PALLADIUM, PERFOLIATE HONEYSUCKLE, PETUNIA AXILLARIS, PULSATILLA VULGARIS, PYRENEES STAR OF BETHLEHEM, SCOTCH BROOM, TRILLIUM CHLOROPETALUM, YELLOW JASMINE, YERBA SANTA, ZINNIA ELEGANSApex Energetics Inc.bca69508-0934-ecfc-e053-2995a90a0ce32024-01-08WarningsExact identifier
unii: 451W47IQ8X
F26 PRSVRALLIUM CEPA WHOLE, APIS MELLIFICA, AURUM METALLICUM, BORAGE, BROMUS RAMOSUS, CALIFORNIA WILDROSE WHOLE, ENGLISH ELM ING TWIG, ENGLISH HAWTHRON, ENGLISH OAK, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, GORSE, LARIX DECIDUA, LUFFA OPERCULATA, MERCURIUS SOLUBILIS, MULLEIN, NATRUM MURIATICUM, PENSTEMON DAVIDSONII WHOLE, PLATINUM METALLICUM, PULSATILLA VULGARIS, PURPLE LOOSESTRIFE WHOLE, ROSA CHINENSIS, SCOTCH BROOM, SEPIA, WILD MUSTARD, YERBA SANTA, ZINCUM METALLICUMApex Energetics Inc.beaef254-bf57-df92-e053-2995a90abd652024-01-08WarningsExact identifier
unii: 451W47IQ8X
G05 OXI-METADENOSINE TRIPHOSPHATE, IGNATIA AMARA, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, SULPHURApex Energetics Inc.beb18213-911a-38d4-e053-2a95a90ac17c2024-01-08WarningsExact identifier
unii: 451W47IQ8X
N04 RAD-TOXALOE SOCOTRINA, BONE MARROW SUIS, BOS TAURUS PLACENTA, BOS TAURUS SKIN, DNA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, FERRUM METALLICUM, FUCUS VESICULOSUS, IODIUM, KALI PHOSPHORICUM, PHOSPHORUS, RIBES NIGRUM FLOWER BUD, SOY LECITHIN, VITAMIN A ACETATE, VITAMIN E ACETATEApex Energetics Inc.bd08de24-ee4d-12bc-e053-2995a90a87b82024-01-08WarningsExact identifier
unii: 9E8X80D2L0
LIVER PLUS FormulaADENOSINE TRIPHOSPHATE, IGNATIA AMARA, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, SULPHURApex Energetics Inc.d8c7b349-8718-d8ed-e053-2995a90ae9882024-01-08WarningsExact identifier
unii: 451W47IQ8X
S01 ALLERDRAINALOE SOCOTRINA, BERBERIS VULGARIS, BETULA VERRUCOSA, BRYONIA, CARDUUS MARIANUS, ECHINACEA ANGUSTIFOLIA, GINKGO BILOBA, HISTAMINUM HYDROCHLORICUM, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, MELALEUCA ALTERNIFOLIA OIL, QUERCUS ROBUR, RHAMNUS PURSHIANA, RIBES NIGRUM, ROSA CANINA, ROSMARINUS OFFICINALIS, SCROPHULARIA NODOSA, SENNA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, VACCINIUM VITUS IDAEAApex Energetics Inc.b9d2a7ef-28bd-4882-e053-2a95a90a0fdd2024-01-08WarningsExact identifier
unii: VIF565UC2G
Principal Secret Advanced with Hydrospheres Continuous Moisture SPF8OCTINOXATE AND OCTISALATEGuthy-Renker LLCf4310455-8b3f-40a9-8674-fe7fc3abaced2024-01-08WarningsExact identifier
unii: 4X49Y0596W
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
unii: 059QF0KO0R
Aruba Sun SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%Derma Care Research Labs,LLCd8b4f8c4-811b-4139-e053-2995a90a04c22024-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLC037ac04d-f8f3-4bb8-993a-ac8f7683ff832024-01-04Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GINZING SPF 30 DAILY MOISTURIZERAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEORIGINS NATURAL RESOURCES INC.0e106c03-4c25-5bfb-e063-6294a90ab3e12024-01-03WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
GAS RELIEF EXTRA STRENGTHSIMETHICONEYYBA CORPcc79435e-6d4b-b283-e053-2995a90a8db32024-01-03WarningsExact identifier
unii: 92RU3N3Y1O
Avon Anew Platinum Day-Cream SPF 25 SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Avon Company148203ef-7d73-369c-e063-6394a90a0e582024-01-03WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
Avon Anew Ultimate Day Multi-Performance-Cream SPF 25 SunscreenAVOBENZONE, HOMOSALATE, OCTINOXATE, OXYBENZONEThe Avon Company14833e71-704d-9a88-e063-6394a90a31b22024-01-03WarningsExact identifier
unii: G63QQF2NOX
ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum SunscreenOCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDEAmway Corpa1a700b5-d039-4bd2-8420-5c20530957062024-01-02WarningsExact identifier
unii: 4X49Y0596W
Garnier green labs Replumping HyaluMelon Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc5bece3c9-c310-4fb2-b644-507407fcfb082024-01-02WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Childrens Mylicon All in One Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.0952eba8-6de2-4a77-956d-339fab4374722024-01-01WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Maximum Strength Vanilla Caramel FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.ace5cae4-3a78-41c3-987d-59ce22dca2ac2024-01-01WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.